Units
2.0 QUARTER UNITS
Cost
$785
Skills you will gain
- Clinical Trial Planning: Strategic setup and execution of research activities.
- Budget & Timeline Management: Cost control and scheduling for project success.
- Team Leadership: Guidance of research teams and site performance oversight.
- Project Management Tools: Utilization of software and methodologies for trial tracking.
- Regulatory Strategy Development: Integration of compliance and risk assessment techniques.
Course Description
This course presents the effective planning and management of drugs and biologics clinical research trials. Exercises and case studies will illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic clinical development plans, team and clinical site performance problems are also discussed.
This course will benefit clinical research professionals who are planning to begin or like to manage clinical research studies.
Topics
- Project development and management
- Building a Quality Management Plan
- How/Why Clinical Trial fails?
- Using Metrics to improve trial management
Additional Information
Students should have a broad educational background with courses in computers and public health science management. Completion of a general course in the content area of Clinical Research, or 2 years of experience in the Clinical Research workplace.
Professional Credit
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 20 contact hours
You may enroll in this offering at any time.
Feb. 16 - Mar. 30, Tue, 6:30pm - 9:30pm
- Live-Online Attend via Zoom at scheduled times.
CTDM.X401.(15)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Tue, 02-16-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 02-23-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-02-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-09-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-16-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-23-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-30-2027 | 6:30pm | 9:30pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Required Tools & Materials:
The New One Minute Manager, Kenneth H. Blanchard and Spencer Johnson, 2015. ISBN: 9780008128043.
Recommended Tools & Materials:
21 CFR Title 21 Parts 50, 54, 56, 312 available on http://www.fda.gov
ICH guidelines E6 (Good Clinical Practice), E8 (General Consideration for Clinical Trials) available on http://www.ich.org
This course applies to these programs:
